The US Food and Drug Administration (FDA) may likely decide to grant accelerated approval to the experimental dementia drug named Lecanemab. The drug, manufactured by drug companies Eisai and Biogen, is one of the first medications that shows significant promise in the treatment of Alzheimer’s disease.
Eisai spokesperson Libby Holman confirmed that
“If lecanemab is approved by the FDA under the Accelerated Approval Pathway, Eisai will do its best to make lecanemab available as soon as possible,”
The American Alzheimer’s Disease Association expects the FDA to announce a decision by January 6.
Maria Carillo, the association’s science officer said, We believe, based on the totality of positive data from clinical trials of this treatment, that the FDA should approve. Peer-reviewed, published results show lecanemab will provide patients in the earliest stages of Alzheimer’s more time to participate in daily life and live independently. It could mean many months more of recognizing their spouse, children and grandchildren.”
Alzheimer’s disease is a form of dementia that usually starts with memory loss and gets worse over time. Brain cells die and the brain shrinks which leads to deficits in cognitive functions, such as memory, language skills, and behavior.
Guyana’s health minister Dr. Frank Anthony had spoken about the disease last September during Alzheimer’s Awareness Month.
The Minister said, “The estimate right now is that one in six persons between 80 and 85 years of age would have Alzheimer’s or dementia. One in three persons above 85 would have Alzheimer’s, and one in two above 90 would have Alzheimer’s, so age is really an important factor here.”
Minister Anthony spoke of the symptoms of the disease. He said, “What we need to look at is initially the disease would present with very subtle changes. So, people start losing their memory gradually, they are not remembering things, you might say something to them, they forget what you have just said to them, they repeat themselves, so they may tell you something now, repeat that a little, a few minutes, so they can’t remember what they have said to you.”
Dr. Anthony noted that, “It’s very important that if you find that an older relative or someone in your care is having these signs and symptoms, is for them to come to the hospital so that the doctors can make that diagnosis and probably advise on treatment and be able to give you better advice on how to care for these persons.”
Meanwhile, clinical trials of the drug indicate that there may be side effects The most common adverse events in the lecanemab group were reactions to the intravenous infusions and abnormalities on their MRIs, such as brain swelling and bleeding called amyloid-related imaging abnormalities, or ARIA, which can become life threatening.
Experts assure that even after the drug is approved, patients will be monitored and studies of the medication’s effects will continue. However, experts across the medical community report excitement and optimism regarding the drug’s potential benefits.